Kornimate/medical-research-clean huggingface dataset:
frailty in individuals with advanced heart failure part 2

Conditions: Heart Failure; Frailty

Summary: to investigate how measures of frailty, assessed during occupational therapy (ot) evaluation and intervention impact decision for advanced heart failure (hf) therapies and postoperative outcomes.


Eligibility criteria:
inclusion criteria: * individuals will be included in this study if they were evaluated for advanced heart failure therapies at keck hospital from 1/1/2019-6/30/2021. this will be determined through data from the electronic medical record. exclusion criteria: * patients who did not receive an occupational therapy evaluation prior to advanced heart failure intervention decision.
emergency medicine palliative care access

Conditions: Advanced Cancer; End Stage Organ Failure

Summary: this is a two-arm, multi-site randomized controlled trial of 1,350 older adults (50+ years) with either advanced cancer (defined as metastatic solid tumor) or poor prognosis end-stage organ failure (new york heart association (nyha) class iii or iv congestive heart failure (chf), end-stage renal disease (esrd), defined as glomerular filtration rate (gfr) \< 15 ml/min/m2 or dialysis ; or global initiative for chronic obstructive lung disease (gold) stage iii or higher, or oxygen-dependent chronic obstructive pulmonary disease (copd) who present to the emergency department (ed), along with 675 of their informal caregivers. investigators will compare the effectiveness of two distinct palliative care models: a) nurse-led telephonic case management; and b) facilitated, outpatient specialty palliative care.


Eligibility criteria:
inclusion criteria: patients: * english or spanish-speaking patients ages 50 years and older * qualifying serious, life-limiting conditions and who are scheduled for ed discharge, observation status, or admission for two midnights or less. * qualifying conditions include: advanced cancer (defined as metastatic solid tumor) or poor prognosis end-stage organ failure new york heart association (nyha) class iii or iv congestive heart failure (chf), end-stage renal disease (esrd), defined as glomerular filtration rate (gfr) \< 15 ml/min/m2 or dialysis; or global initiative for chronic obstructive lung disease (gold) stage iii or higher or stage iii or iv, or oxygen-dependent chronic obstructive pulmonary disease (copd) defined as global initiative for chronic obstructive lung disease (gold) * patients must have health insurance, reside within the geographical area, and have a working telephone. informal caregivers: * english or spanish-speaking primary caregivers (relative or friend who has contact with the patient at least two times per week) ages 18 years and older. exclusion criteria: * patients with dementia identified in the ehr, who received hospice services in the last six months, who have received 2 or more palliative care visits in the last 6 months, and those who reside in a skilled nursing or assisted living facility, or chronic care hospital.
repetitive transcranial magnetic stimulation (rtms) in the treatment of obsessive compulsive disorder

Conditions: Obsessive-Compulsive Disorder

Summary: this study will evaluate the possible therapeutic effects of repetitive transcranial magnetic stimulation(rtms) in obsessive-compulsive disorder (ocd) in ocd patients who have not fully responded to pharmacotherapy, and the underlying neural mechanism by eeg.

the purpose of study is to examine the efficacy of rtms over different brain areas, including the bilateral supplement motor area (sma), the right dorsal lateral prefrontal cortex (dlpfc) and sma+dlpfc in the treatment of ocd. 120 ocd patients will be randomized into four groups. continuous theta burst stimulation (ctbs) stimulation will be performed once a day, five times a week, for four weeks. the investigators will assess improvement after four weeks of ctbs. though the study, yale-brown obsessive compulsive scale（y-bocs）, the dimensional yale-brown obsessive-compulsive scale (dy-bocs), the barratt impulsiveness scale-11 (bis-11), the beck depression inventory(bdi), the beck anxiety inventory (bai), perceived stress scale(pss), pittsburgh sleep quality index(psqi), the obsessive-compulsive inventory-revised(oci-r) and side effects will be obtained by a trained investigator. the patients will also receive magnetic resonance imaging scan and electroencephalography (eeg).

Eligibility criteria:
inclusion criteria: * age\>18 years old; * dsm-5 criteria for ocd; * y-bocs total score \> or = 16, despite treatment with an adequate trial of a serotonin reuptake inhibitor (sri) and currently using adequate, stable dose of sri at least 4 weeks. an adequate sri trial is defined as treatment for at least 12 weeks on the sri, that meets or exceeds the recommended dosage level for ocd; * \>or＝9 yrs education exclusion criteria: * any additional current psychiatric comorbidity, except for obsessive-compulsive personality disorder * serious suicide risk; * the inability to receive rtms because of metallic implants, or history of seizures，or history of head injury, or history of neurosurgery; * any major medical disease; * pregnancy or nursing of an infant; * participation in current clinical study; * current use of any investigational drug; * tms/dbs treatment at any point in their lifetime; * history of long-time use of benzodiazepines
stereotactic radiotherapy in association with immunotherapy for the treatment of nsclc brain metastases

Conditions: Brain Metastases From NSCLC

Summary: the study's primary objective is the evaluation of toxicities reported during rs or hfsrt in patients with brain metastases from nsclc undergoing immunotherapy (safety), with particular reference to the rate of symptomatic radionecrosis and intralesional hemorrhage. others primary objectives of the study are the feasibility and the intracranial control of the disease, both local (site radiotherapy treatment) and at a distance (intracranial, but at a distance from the site of the disease treated with stereotaxic radiotherapy). the secondary objectives concern quality assessment of life of the patients under study (quality of life, qol).


Eligibility criteria:
inclusion criteria: * age\> 18 years * ability to express informed consent * histological or cytological diagnosis (possibility of pdl-1 determination) of nsclc * - brain metastases up to a maximum of 10 and all treated with rs or hypofractionated stereotactic radiotherapy (3 to 5 fractions) * brain disease assessable according to irano criteria * radiation therapy on brain metastases within 4 weeks before or after infusion of immunotherapy in the following settings * brain metastases at initio brain metastases treated with rs + 1st line therapy * brain metastases as i progression after i line of systemic therapy cht, it or chtit regardless of whether or not the same line is continued (treatment beyond progression) or shift to the next line; * brain metastases as ii progression after ii line of systemic therapy (cht, it) regardless of whether it is continued or not of the same line (treatment beyond progression) or shift to the next line. * diagnostic brain mri for brain metastases within one month of treatment stereotactic esclusion criteria: * life expectancy of less than 6 months (calculated with gpa score \<2) * performance status\> 2 * previous radiotherapy treatment at the brain site * contraindication to mri of the brain with contrast medium * presence of a number of intracranial metastases\> 10 * inability to express informed consent * infusion of immunotherapy more than 4 weeks before and after radiotherapy * impossibility of recording times and dosages of administration of steroid therapy * ineligibility for immunotherapy treatment exclusion criteria: -
substitution of first phase insulin response in patient with type 2 diabetes.

Conditions: Type 2 Diabetes

Summary: the purpose of the project is to shown whether a little dose of a short acting insulin analogue given 3 time daily before the meals compared with placebo could normalise the increase in blood glucose after teh meals in diet treated type 2 diabetic patients.

patients with type 2 diabtes has a defect in the insulinsecretion combined with an increased insulin resistance. at an intravenously glucosestimulation, patients with type 2 diabtes has a decresed first phase insulin response compared to healty peoples. because the hyperglycemia after meal, observed i type 2 diabetics patients, is related to the defect in the first phase insulin response it is our hypothesis that substitution of the first phase insulin response with a little dose of insulin could normalise the blood glucose after the meal. 20 patients with type 2 diabetes will in a randomised, placebocontrolled, dobble-dummy study be included for three days treatment with insulin aspart vs placebo. primary endpoint is bloodglucose fluctuations monitored by a continously glucose monitor.

Eligibility criteria:
inclusion criteria: type 2 diabtes according to the who criteria fasting blood glucose \>7 hba1c between 6-9 normal liver function normal renal function - exclusion criteria: ongoing treatment with antidiabetic medicine pregnancy and lactation -

Keywords: type 2 diabtes postprandial hyperglycemia insulin treatment
naltrexone treatment for prolonged grief disorder (pgd)

Conditions: Prolonged Grief Disorder

Summary: this is a study to see how effective oral naltrexone is as treatment for prolonged grief disorder (pgd). participants will take their assigned medication for 8 weeks, with monthly visits to assess symptom severity, social connectedness, and adverse reactions.


Eligibility criteria:
inclusion criteria: 1. 18 years of age or older. 2. lives within a reasonable distance from nyph for convenient clinic visits. 3. can speak, read, and write english proficiently. 4. meet diagnostic criteria for pgd based on the dsm guidelines 5. if a female patient, must agree to use a method of contraception and be willing and able to continue contraception during the first 8 weeks of the study while she is taking the study drug. female patients who are planning to use oral hormonal contraception during this time must have initiated it at least 2 months prior to the baseline visit. 6. if a male patient, must agree to use a method of contraception and be willing and able to continue contraception during the first 8 weeks of the study while he is taking the study drug. exclusion criteria: 1. having recently started taking/prescribed medications for any psychiatric illness (e.g. ssris for mdd) within the past 3 months; participants who have been taking this medication for longer than 3 months can be included. 2. having recently started psychotherapy for any psychiatric illness within the past 3 months; participants who have been receiving psychotherapy for longer than 3 months can be included. 3. prior history of recently active (e.g. within the past 3 months) opioid dependence. 4. current prescription, non-prescription, or illicit opioid use, (i.e., acute use within the past 14 days or chronic use within the last 30 days), including opioid antagonists for alcohol or opioid dependence, all opioid analgesics, certain cough and cold remedies (e.g., codeine), and certain anti-diarrheal preparations (e.g., loperamide). 5. possible future use of opioids during the study (e.g. for surgery). 6. current use of leflunomide (arava), droperidol (droleptan), diazepam (valium), thioridazine (mellaril, novoridazine, thioril), or any other clinically relevant medication that has potential to cause liver injury with concurrent use of naltrexone. 7. currently pregnant, lactating, or planning to become pregnant during the study. 8. active hepatitis or liver disease. 9. alanine aminotransferase (alt) or aspartate aminotransferase (ast) levels more than one standard deviation (sd) above the upper limit of normal on initial laboratory examination. 10. screen positive for active suicidal thoughts or behaviors.

Keywords: naltrexone
double-blind, placebo-controlled trial of vitamin e as add-on therapy for children with epilepsy

Conditions: Epilepsy

Summary: this is a study to see if vitamin e helps children with epilepsy have fewer seizures. about 20-30% of children with epilepsy do not have adequate seizure control with established antiepileptic drugs (aeds). other options for patients with uncontrolled epilepsy are newer antiepileptic medications, ketogenic diet and surgery. however, a small percentage of patients are candidates for these options. therefore, additional treatments are needed to improve seizure control in patients with uncontrolled epilepsy. animal studies have shown an association between vitamin e supplementation and seizure reduction. a study in children also showed that vitamin e helped reduce seizures. however, a similar study in adults did not show a reduction in seizures with vitamin e supplementation. therefore, this research study is being done to help define vitamin e's usefulness and safety as a treatment for epilepsy. fifty patients will be recruited from the children's epilepsy program at the children's hospital in denver, colorado. qualifying patients will have a confirmed diagnosis of epilepsy that is currently uncontrolled with standard aeds. the study period is 6 months and includes the following: baseline period (1 month), arm i (2 months), wash-out period (1 month), and arm ii (2 months). patients must have been on the same aeds for 2 months before enrollment. all medications and complementary therapies must remain constant throughout the study. if at any point the physician feels it is not best for the patient to continue the study they will be discontinued. before the study starts, study participants will be asked about seizure activity, what they eat and about any complementary and/or alternative medicine they may use. the study is two phases. study participants will be given either vitamin e or placebo (fake pill/liquid) in each phase of the study. they will receive both vitamin e and placebo during the study. which phase they receive vitamin e and placebo will be decided by chance (similar to rolling dice). study participants will take liquid vitamin e or placebo two times per day. the study participants and study doctors will not know who is taking vitamin e and who is taking placebo. study participants will come to the hospital for 3 outpatient and 2 inpatient visits. health-related quality of life questionnaires will be filled out and blood will be drawn at three of the visits. seizure diaries will be maintained throughout the study.


Eligibility criteria:
inclusion criteria: * diagnosis of intractable epilepsy, defined as 1) at least 4 seizures per month; 2) failure of at least 3 standard aeds eeg within the last 6 months * measurable seizure occurrence (parent/caregiver is able to count the number of seizures in any given time period) * stable aed regimen, with at least one standard aed for at least 2 months prior to enrollment * no vitamin e supplementation (except as in standard multivitamin for age) for 6 months prior to study entry
the efficacy and cerebral mechanism of intradermal acupuncture for major depressive disorder

Conditions: Major Depressive Disorder

Summary: major depressive disorder (mdd) is highly prevalent, affecting nearly 4% of the global population. pharmacotherapy is the frontline treatment recommended by the guideline, but it also has some limitations such as delayed onset, inadequate response, and drug resistance. intradermal acupuncture (ia) is a method of using short indwelling needles retained under the skin to produce continuous stimulation for long-term efficacy. it has been reported that ia combination medication appears to be more valuable than medication alone in the treatment of mdd, however, there is a lack of high-quality clinical evidence.while several studies have proposed that manual or electroacupuncture can improve mdd symptoms by modulating brain networks, the cerebral mechanism of ia as superficial acupuncture for mdd has not been reported. hence, investigators designed a multicentre randomized controlled trial to assess the clinical efficacy and safety of ia for mdd and preliminarily explore the potential therapeutic mechanisms for ia by functional magnetic resonance imaging (fmri) .

a total of 120 patients with mdd who meet the inclusion criteria will be included in the study. participants will be randomly assigned 1:1:1 to the waiting list group (patients in this group will be treated with selective 5-hydroxytryptamine reuptake inhibitors (ssris) only), sham intradermal acupuncture combined with ssris (sia) group and active intradermal acupuncture combined with ssris (aia) group. the study will assess the efficacy and safety of intradermal acupuncture for mdd. in addition, investigator will explore the possible cerebral mechanisms by which ia exerts its antidepressant effects.

Eligibility criteria:
inclusion criteria: 1. patients diagnosed with mdd according to the international classification of disease-10 (icd-10); 2. aged between 18 and 60 years (no limitation on gender); 3. administration of ssris; 4. patients undergoing mri and mrs should be right-handed and free of traumatic brain injury, claustrophobia or metal implants; 5. written informed consent is obtained by the person or guardian. exclusion criteria: 1. icd-10 diagnoses: schizophrenia, bipolar disorder, manic episode or other psychotic disorders; alcohol and drug addiction; 2. significant skin lesions, severe allergic diseases, tumors, and severe or unstable internal diseases involving the cardiovascular, digestive, endocrine, or hematological system; 3. acute suicidal tendency; 4. allergy to adhesive tape and fear of intradermal acupuncture; 5. pregnancy and lactation; 6. mental retardation and difficulty cooperating with doctors. 7. participating in other clinical trials.

Keywords: major depressive disorder intradermal acupuncture magnetic resonance imaging
triamcinolone acetonide injections in mild-to-moderate chronic plaque psoriasis with a novel needle-free drug-delivery system

Conditions: Psoriasis

Summary: this is an observational pilot study comparing triamcinolone acetonide injections with the investigational med-jet needle-free drug-delivery system as an alternative to using a conventional syringe and needle in patients with mild-to-moderate psoriasis. there will be five (5) visits necessary for study participation. the hypothesis is that the efficacy, safety, pain tolerance, and quality of life (qol) metrics of the med-jet needle-free drug-delivery system will be equal to or superior to that of a conventional syringe and needle.


Eligibility criteria:
inclusion criteria: * diagnosed with plaque-type psoriasis defined by either: * a board-certified dermatologist, or * dermatology nurse practitioner, or * skin punch biopsy * involvement of body surface area (bsa) \< 10% at screening and baseline visit. * the presence of plaque-type psoriasis at least two (2) plaques that are at least two (2) cm² in areas of the trunk, buttock, or extremities that are either: * symmetrically located on contralateral body site or * within the same body site but separated by ≥ 1 cm * able to give informed consent under irb approval procedures exclusion criteria: * known allergy or hypersensitivity to triamcinolone acetonide * pregnant, breastfeeding, or planning to get pregnant 4 weeks before, during, and 4 weeks after the study. * inability to provide informed consent * active untreated diseases or medication usage which may interfere with wound healing and immune function (anti-neoplastic, systemic immunosuppressants, anticoagulants, daily nsaids) * use of tanning booths for at least 4 weeks prior to baseline visit * current or recent use of topical steroid, tar, phototherapy, vitamin d, or retinoid therapy to target lesions for at least 2 weeks prior to baseline visit * current or recent use of systemic or biologic therapy for at least 4 weeks or 5 half-lives of the drug (whichever is longer) prior to baseline visit

Keywords: triamcinolone acetonide med-jet
blepharospasm short interval

Conditions: Blepharospasm

Summary: the objective of this phase ii study is to show that pre-treated patients with beb with the need of shortened injection intervals achieve an improved and stable quality of life level if they receive repeated nt 201 injections at short injection intervals. in addition, the tolerability of repeated shortened nt 201 administrations in patients with beb including the development of neutralizing antibodies will be investigated.


Eligibility criteria:
inclusion criteria: * a clinical diagnosis of bilateral beb characterized by spontaneous, spasmodic, intermittent or persistent involuntary contractions of the orbicular oculi muscles * medical need for treatment with shortened injection intervals (\< 12 weeks) confirmed by the patient and investigator * blepharospasm disability index (bsdi) at baseline visit before injection of \> / = 1,6 exclusion criteria: * atypical variant of blepharospasm caused by inhibition of levator palpebrae muscle (apraxia of the eyelid) * generalized disorders of muscle activity (e.g. myasthenia gravis, lambert-eaton syndrome), as well as amyotrophic lateral sclerosis or any other significant neuromuscular disease which might interfere with the trial * the previous three injections with botulinum toxin type a with more than 50 units \[u\] per eye per injection session * treatment with botulinum toxins for any indication other than beb within 4 months prior to baseline and during the trial
non-nicotine agents for smoking cessation

Conditions: Tobacco Use Disorder

Summary: the primary objective of this study is to determine which is the better approach to smoking cessation in veterans: bupropion combined with transdermal nicotine or high dose nicotine replacement therapy (nrt) using transdermal nicotine combined with nicotine inhaler.

this study is a two-arm open-label, randomized controlled trial of bupropion combined with transdermal nicotine versus high dose nrt (transdermal nicotine and nicotine inhaler) with all subjects receiving a behavioral counseling program for smoking cessation.

Eligibility criteria:
inclusion criteria: * readiness to set a quit date in the next two weeks, * current smoking of at least 15 cigarettes a day exclusion criteria: * current untreated depression or receiving treatment for depression, * history of seizures, major head injury, or other predisposition for seizures

Keywords: smoking nicotine drug therapy smoking cessation